Autoinjector

ABSTRACT

An autoinjector having a lower body ( 10; 1010 ) receiving a reservoir, a piston, a needle, an actuating sleeve ( 11; 1011 ) with a contact end to contact the user. The actuating sleeve is displaceable between projected positions and an actuation position, being in a first projected position prior to actuation of the autoinjector. The autoinjector also having an injection device ( 5, 8; 1005, 1008 ) and an injection lock. The actuating sleeve is automatically returns to the second projected position when the user removes the autoinjector from his body and is locked in this second projected position. The autoinjector includes an external shell ( 22; 1022 ) having a display window for indicating the actuation sequences, at least one display window ( 221; 1221; 1023 ) indicating to the user that the injection of the fluid product is finished.

BACKGROUND OF THE INVENTION

The present invention relates to an autoinjector.

Autoinjectors are well known in the prior art. The main aim of thesedevices is to carry out automatic injection of the contents of a syringeinside the body of a patient. There are various systems for automatingpenetration of the needle into the body of the patient as well asinjection of the fluid product contained in the syringe. Autoinjectorsare relatively complex devices which must respond to a certain number ofrequirements of stresses to be reliable. The robustness of the device,its handling, and its ease of use for the user are also importantelements. In addition, as the majority of these autoinjectors is singleuse, the cost of manufacture and assembly is also a factor to be kept inmind.

There are numerous autoinjectors on the market, all of which howeverhave some disadvantages.

Therefore, to prevent untimely triggering of the autoinjector, forexample during transport or storage, devices must comprise reliablelocking means. Similarly, when a user wants to utilise the autoinjectorand unlocks the device, for example by removing the cap, the device mustnot actuate prematurely but only when the user really wants it, that is,at the moment when he applies it to the part of the body in which hewants to carry out the injection. Now, especially when those peopleusing the autoinjector are elderly or handicapped people, it can happenthat the user drops the device just when he wants to use it. It ispreferable in such a case that the autoinjector does not actuate on itsown. It is therefore important to provide a reliable triggering lock.From another viewpoint, using the autoinjector should not become toodifficult, which would prevent weak people from using it. It istherefore difficult to find a good compromise between the security ofthe locking and the ease of use and actuation of the autoinjector. It isone of the aims of the present invention to respond to this problem.

In addition, according to the volume of the fluid product distributedduring injection and also as a function of its viscosity, the timeneeded to complete this injection can be fairly substantial, and mayespecially exceed several second. It is very important that the user notremove the device from his body before the injection is complete. It istherefore preferable for the device to comprise means for indicatingreliably to the user that the injection is finished.

It is also important to ensure that the product is injected to thecorrect depth in the body, that is, in the right tissue. So masteringthe start of injecting, to ensure that the latter will start only whenthe needle reaches its definitive pricking position, is therefore alsoan important aspect.

Also, to avoid any risk of injury after use of the device, theautoinjector must comprise a needle safety device which prevents theneedle from being conspicuous after use of the device. This safetydevice must obviously also be reliable and not be released too easily.It must also be functional even if the user improperly activates theautoinjector, for example if he removes it too early from his body,prior to completion of the injection.

Another important aspect of autoinjectors, especially when the volume offluid product is relatively large and/or when the fluid product injectedis relatively viscous, is to allow the product to diffuser from theinjection site for a few seconds after said injection. If the userremoves the autoinjector immediately after the end of the injection,part of the product can flow back out of the body of the user, whichdiminishes the efficacy of the treatment. It is therefore preferable toprovide that the user holds the autoinjector against his body for a fewmore seconds after the end of the injection. This aspect is generallyresolved by existing autoinjectors by the notice of use which asks theuser to count in his head for a certain number of seconds beforeremoving the device. This is not reliable and therefore unsatisfactory,as the system then depends on the user himself who in some cases can beperturbed or weakened by what he has just done.

Documents WO2012045833, EP1743666, WO2009095701, WO2012022810,EP2399632, FR2884722, WO9632974, WO2012000832, U.S.2008281271,WO2009040602, WO2009040604, WO2009040607, WO2010108116, WO2011048422,EP2399628, WO2008112472, WO2011101380, WO2011101382, U.S.2005273055,FR2905273, WO2009062508, WO2009037141 and GB2463034, describe devices ofthe prior art.

SUMMARY OF THE INVENTION

The aim of the present invention is to provide an autoinjector whichdoes not reproduce the abovementioned disadvantages and which respondsto the different requirements and considerable restrictions for safe andreliable use of the autoinjector.

Another aim of the present invention aim is to provide an autoinjectorwhich is reliable in use, which ensures distribution of all the fluidproduct at the planned site, which allows the user to determine when hemust remove or when he can withdraw the autoinjector from his body afterits use, which is safe and which avoids any risk of injury, and which issimple and not costly to manufacture and assemble.

The aim of the present invention is therefore to provide an autoinjectorcomprising a lower body receiving a reservoir, said reservoir containingfluid product and comprising a piston and a needle, such as a pre-filledsyringe, said autoinjector comprising:

-   -   an actuating sleeve provided with a contact end designed to make        contact with the body of the user, said actuating sleeve being        displaceable between projected positions and an actuation        position, said actuating sleeve being in a first projected        position prior to actuation of the autoinjector and in a second        projected position after actuation of the autoinjector,    -   injection means to inject said fluid product through said needle        when said needle is in the injection position,    -   an injection lock to block said injection means,    -   said actuating sleeve being automatically returned to said        second projected position when the user removes the autoinjector        from his body, said actuating sleeve (11; 1011) being locked in        this second projected position, preventing any other actuation        of the autoinjector,

wherein said autoinjector comprises an external shell comprising atleast one display window for indicating visually to the user theactuation sequences of the autoinjector, at least one display windowindicating to the user that the injection of the fluid product isfinished.

Advantageously, the autoinjector comprises a reservoir displacementdevice on the one hand to displace the needle towards an injectionposition in which it is inserted in the body of the user and on theother hand to retract said needle out of the body of the user afterinjection of the fluid product, said actuating sleeve, in the actuationposition, actuating said reservoir displacement device to move theneedle towards its injection position, said reservoir displacementdevice unblocking said injection lock and actuating the injection meanswhen the needle is in the injection position, in which said injectionmeans actuate said reservoir displacement device after injection of thefluid product to retract said needle.

Advantageously, said reservoir displacement device comprises a controlslide displaceable axially in said autoinjector during the actuation,said control slide comprising at least one indicator, such as a colourzone, evident through said at least one display window.

Advantageously, said injection means actuate a trigger which actuatesthe retraction of the needle after a predefined rotation, said triggercomprising at least one indicator, such as a colour zone, evidentthrough said at least one display window.

Advantageously, said external shell comprises a first display windowindicating to the user that the injection of the fluid product isfinished and that the needle is in a retracted position.

Advantageously, said external shell comprises a second display windowindicating to the user that the phases of pricking and injection of thefluid product are underway.

Advantageously, said external shell comprises a third display windowindicating to the user that the actuating sleeve is in a projectedposition.

Advantageously, the autoinjector comprises a retarding device adapted toretard during a predetermined time the actuation of said reservoirdisplacement device by said injection means after injection of the fluidproduct, to delay retraction of said needle of said predetermined timeafter the end of the injection.

Advantageously, said external shell comprises a display windowindicating the flow of said predetermined time to the user.

Advantageously, the autoinjector comprises a control sleeve displaceableaxially relative to said external shell between a first locking positionin which it locks the injection lock, and a second unlocking position,in which it allows unblocking of the injection lock and therefore theinjection of the product through the needle, said control sleeve beingdisplaced from its locking position towards its unlocking position bysaid actuating sleeve.

Advantageously, said control sleeve is also displaceable axiallyrelative to said external shell between said second unlocking positionand a third final position, in which it has actuated a sound and/ortactile indication device to inform the user of the end of injection.

Advantageously, said external shell comprises a display window adaptedto indicate the different axial positions of said control sleeve.

Advantageously, said external shell comprises at least one displaywindow formed in the distal end edge of said external shell, by beingevident at the same time in the axial direction and in the radialdirection of said external shell.

BRIEF DESCRIPTION OF THE DRAWINGS

These characteristics and advantages and others of the present inventionwill emerge more clearly from the following detailed description, givenin reference to the attached drawings, given by way of non-limitingexamples, and in which:

FIG. 1 is a schematic exploded view in perspective of the components ofan autoinjector, according to a first advantageous embodiment,

FIGS. 2a to 2f are schematic views in transversal section illustratingthe different sequences of use of the autoinjector of FIG. 1,

FIGS. 3a à 3 c illustrate more precisely three different stages of anadvantageous actuating sleeve, respectively before, during and afteruse,

FIG. 4 is a detailed view showing the actuating sleeve in the positionof FIG. 3 a,

FIGS. 5 and 6 are schematic views in transversal section according totwo different sectional planes showing the actuating sleeve in theposition of FIG. 4,

FIGS. 7 and 8 are partially cut schematic views in perspectiveillustrating the actuating sleeve in the position of FIGS. 5 and 6,

FIG. 9 is a view similar to that of FIG. 4, at the start of actuation ofthe autoinjector, during the pricking phase,

FIGS. 10 to 11 are views similar to FIGS. 5 and 6, in the position ofFIG. 9,

FIG. 12 is a view similar to that of FIG. 8, in the position of FIGS. 10and 11,

FIG. 13 is a view similar to that of FIGS. 4 and 9 during actuation, inthe injection phase,

FIGS. 14 and 15 are views similar to those of FIGS. 10 and 11illustrating the position of FIG. 13,

FIG. 16 is a view similar to that of FIG. 12, illustrating the positionof FIGS. 14 and 15,

FIG. 17 is a view similar to that of FIG. 13, at the end of actuation,when the user removes the autoinjector from the injection site,

FIG. 18 is a view similar to that of FIG. 17, when the actuating sleeveis locked,

FIG. 19 is an exploded schematic view in perspective illustrating anadvantageous injection lock,

FIG. 20 is a sectional transversal schematic view of the injection lockof FIG. 19, in the blocking position,

FIG. 21 is a view similar to that of FIG. 20, in the unblockingposition,

FIG. 22 is a schematic plan view in horizontal section of the injectionlock of FIG. 19, in the blocking position,

FIG. 23 is a partially cut schematic view in perspective of theinjection lock of FIG. 19, in the blocking position,

FIG. 24 is a transversal sectional schematic view of the injection lockof FIG. 19, in the blocking position,

FIG. 25 is a view similar to that of FIG. 23, in the unblockingposition,

FIG. 26 is a view similar to that of FIG. 24 in the unblocking position,

FIG. 27 is an exploded schematic view in perspective of an advantageousretarding device,

FIG. 28 is a transversal sectional schematic view of the retardingdevice of FIG. 27 before its actuation,

FIG. 29 is a sectional schematic view according to the cutting line X ofFIG. 28,

FIG. 30 is a sectional schematic view according to the cutting line Y ofFIG. 28,

FIG. 31 is a view similar to that of FIG. 28, at the end of actuation ofthe retarding device,

FIG. 32 is an exploded schematic view in perspective of an advantageoussyringe displacement mechanism,

FIGS. 33 to 35 are partially cut schematic views in perspective of thedisplacement mechanism of FIG. 32, prior to actuation, according tothree different orientations,

FIGS. 36 and 37 are views similar to FIGS. 33 and 35, during actuationof the displacement mechanism,

FIGS. 38 to 41 are partially cut partial schematic views in perspectiveof the displacement mechanism of FIG. 32, when the needle of the syringehas reached its injection position in the body of the user,

FIGS. 42 and 43 are schematic views of the displacement mechanism ofFIG. 32 at the start of retraction initiated by the retarder,

FIG. 44 is a schematic view of the displacement mechanism of FIG. 32 atthe start of retraction initiated by the actuating sleeve,

FIGS. 45 and 46 are view similar to FIGS. 43 and 44, on completion ofinjection,

FIG. 47 is an exploded schematic view in perspective of the componentsof an autoinjector, according to a advantageous second embodiment,

FIGS. 48a à 48 e are schematic views in transversal section illustratingthe different sequences of use of the autoinjector of FIG. 47,

FIGS. 49a and 49b are schematic views in perspective illustrating thelower body and the actuating sleeve of the autoinjector of FIG. 47,

FIGS. 50a, 50b and 50c schematically illustrate the cooperation betweenthe actuating sleeve and the lower body of the autoinjector of FIG. 47,respectively in position prior to actuation, after actuation but priorto injection and after injection,

FIG. 51 is a view similar to that of FIG. 50a , illustrating a variantembodiment,

FIG. 52 is a detailed cut enlarged view in perspective, showing avariant of the actuating sleeve with breakable bridges,

FIGS. 53a and 53b illustrate schematic views of the autoinjector priorto injection,

FIGS. 54a and 54b are views similar to FIGS. 53a and 53b , afterinjection,

FIG. 55 is a schematic view in perspective of a sound and/or tactileindication device according to an advantageous variant,

FIG. 56 is a view similar to FIG. 55, partially in section,

FIGS. 57a, 57b and 57c show the autoinjector prior to injection,

FIGS. 58a, 58b and 58c show the autoinjector after injection but priorto actuation of the sound and/or tactile indication device,

FIGS. 59a, 59b and 59c show the autoinjector after injection and afteractuation of the sound and/or tactile indication device,

FIG. 60 is a schematic view in perspective exploded illustrating avariant embodiment of the sound and/or tactile indication device,

FIGS. 61 and 62 are schematic views of the control sleeve of the soundand/or tactile indication device of FIG. 61,

FIGS. 63a and 63b are schematic views of the key of the sound and/ortactile indication device of FIG. 61,

FIGS. 64a, 64b and 64c are schematic views of the autoinjector of FIG.60, respectively before unlocking of the injection lock, after unlockingof the injection lock and on completion of injection, illustrating thesound and/or tactile indication device of FIG. 61,

FIG. 65 shows another variant embodiment of the sound and/or tactileindication device,

FIGS. 66a and 66b are schematic views of the support pellet of the soundand/or tactile indication device of FIG. 65,

FIGS. 67a and 67b are schematic views of the key of the sound and/ortactile indication device of FIG. 65,

FIGS. 68a, 68b and 68c are views similar to FIGS. 64a, 64b and 64c ,illustrating the sound and/or tactile indication device of FIG. 65,

FIGS. 69, 70 and 71 are detailed views of FIGS. 68b and 68 c,

FIG. 72 schematically shows a variant embodiment of the actuatingsleeve,

FIG. 73 shows another view of the variant embodiment of FIG. 72, and

FIGS. 74a, 74b and 74c are views similar to FIGS. 50a, 50b and 50c ,illustrating the variant embodiment of the actuating sleeve of FIGS. 71and 72.

DETAILED DESCRIPTION OF THE DRAWINGS

The autoinjector will be described hereinbelow in reference to diversevariants of two advantageous embodiments of the latter. A firstembodiment is shown in FIGS. 1 to 46 and a second embodiment is shown inFIGS. 47 to 74 c. It is however to be noted that these autoinjectors,which are complex devices, comprise several modules for carrying outseveral functions. These diverse modules can be used separately andindependently of each other, without necessarily being combined withother modules, and could especially be used in autoinjectors of formdifferent to that shown in the drawings.

In reference to FIG. 1, the different components of the autoinjector,according to a first advantageous embodiment, are shown exploded. Inthis first embodiment, and in the order of the reference numerals, theautoinjector comprises a central body 1, a control ring 2, a prickingspring 3, a control sleeve 4, a piston rod 5, a pellet support 6, threeblocking elements 7, here in the form of balls, an injection spring 8, acontrol slide 9, a lower body 10, an actuating sleeve 11, a spring 12 ofthe actuating sleeve, a reservoir housing 13, a cap 14, an upper body15, a plurality of planetaries 16, a plurality of satellites 17, aretardant spring 18, a trigger 19, a locking finger 20, a wire 21, anexternal shell 22 and a blocking ring 23. All these elements form partof the embodiment described, but all are not indispensable to theoperation of the autoinjector, as will be described more preciselyhereinbelow.

The cap 14 especially locks the autoinjector during transport andstorage. As this cap is assembled on the lower body 10, it prevents anyactuation of the actuating sleeve 11, and therefore any triggering ofthe autoinjector.

A reservoir A can be inserted into said autoinjector. This reservoircontains fluid product, and comprises a piston and a needle. The pistonis adapted to shift in said reservoir to inject the fluid productthrough said needle. The present description will be given in referenceto a syringe A, which can be any type. More generally, it is understoodthat the term “syringe” in the present description covers any type ofreservoir linked to a needle.

Preferably, the syringe A is a pre-filled syringe. It advantageouslycomprises a needle cap B which protects and isolates the needle prior touse of the autoinjector. Advantageously, this needle cap B is removedautomatically at the moment when the cap 14 is withdrawn from the lowerbody 10.

FIGS. 2a to 2f illustrate the sequences of the use of the autoinjectorof FIG. 1.

In FIG. 2a , the autoinjector is in the rest position prior to use, thecap 14 having been removed.

When the user wants to use the autoinjector, he takes the device, forexample at the level of the external shell 22 and presses the actuatingsleeve 11, which in a first projected position projects out of the lowerbody 10, against the part of the body where he wants to carry out theinjection. In FIG. 2b , it is evident that pressure exerted by the useron the actuating sleeve 11 causes the latter to slide towards theinterior of the lower body 10, with the effect of compression of thespring of the actuating sleeve 12.

When the actuating sleeve 11 reaches its actuation position, which isits end position inside the lower body 10, it causes triggering of thepricking lock and therefore displacement of the control sleeve 4 in thelower body 10 under the effect of the pricking spring 3, consequentlywith displacement of the syringe A in the lower body 10 and thereforeinsertion of the needle of the syringe in the body of the user, as isevident in FIG. 2 c.

When the needle reaches its injection position with complete insertionof the needle, the injection phase is triggered, which is shown in FIGS.2c and 2d . It is noted that the piston rod 5 slides inside the syringeA by pushing the piston of the latter under the effect of the injectionspring 8. The product is therefore distributed.

On completion of the injection, and with optionally a certain delay ortime offset, as will be described later, the autoinjector providesretraction of the syringe A. The needle is therefore retracted out ofthe body of the user towards the interior of the autoinjector, as shownin FIG. 2 e.

On completion of retraction, the actuating sleeve 11 is again displacedout of the lower body 10 towards a second projected position, under theeffect of the spring 12 of the actuating sleeve, with locking of saidactuating sleeve 11, which ensures absolute safety for the user andavoids any risk injury with the needle after use of the device. It isevident that the first and second projected positions of the actuatingsleeve, which in the example shown are different positions, couldoptionally be identical.

An advantageous actuating sleeve will be described in more detailhereinbelow in reference to FIGS. 3a to 18.

Said actuating sleeve 11 comprises a flexible tab 110 which has doubleflexibility. It is on the one hand flexible radially that is, it deformstowards the interior of the actuating sleeve 11. It is then alsoflexible laterally that is, it deforms in the peripheral direction ofthe actuating sleeve 11. An actuating sleeve 11 provided with such aflexible tab is simple to mould, which is favourable from the point ofview of manufacturing costs. The flexible tab 110 advantageouslycomprises a rod part 111 which is flexible and which terminates in ahead part 112. Said flexible tab 110 is adapted to deform on the onehand radially and on the other hand laterally relative to said centralbody 1 when said actuating sleeve 11 is displaced from its firstprojected position towards its actuation position then from its returnactuation position towards its second projected position. Preferably,said flexible tab 110 is deformed radially when said actuating sleeve 11is moved from its first projected position, prior to actuation, towardsits actuation position, and said flexible tab is deformed laterally whensaid actuating sleeve 11 is moved from its actuation position towardsits second projected position, at the end of use. This is the variantwhich is shown in the figures.

FIGS. 3a, 3b and 3c are three partial schematic views in perspectivewhich show the end positions of the actuating sleeve 11, specifically inFIG. 3a the first projected position at rest prior to actuation, in FIG.3b the actuation position in which the actuating sleeve 11 has beeninserted to the maximum inside the lower body 10, and in FIG. 3c thesecond projected position with the actuating sleeve 11 locked relativeto the lower body 10, at the end of use.

It is noted that the central body 1 comprises cutouts forming groovesand shoulders which are detailed hereinbelow. The central body 1 isfixed to the lower body 10 and the actuating sleeve 11 is arranged toslide inside said lower body 10.

The central body 1 comprises a first groove 101, substantially axial,and an opening 103, separate from said first groove 101 but arranged inthe axial extension of said first groove 101. Said central body 1 alsocomprises a radial cam 102 arranged between said first groove 101 andsaid opening 103. As evident especially in FIGS. 6 and 7, said radialcam 102 can be formed by inclined radial thickening of the wall of thecentral body 1, said thickening being formed at the axial end of thefirst groove 101. Said radial cam 102 cooperates with said head 112 ofsaid flexible tab 110 to radially deform said flexible tab 110 and allowsaid head 112 to move from said first groove 10 to said opening 103during displacement of the actuating sleeve 11 towards its actuationposition.

Said central body 1 comprises a final reception zone 105 offset axiallyand laterally relative to said opening 103. As evident in the figures,this final reception zone 105 is arranged axially around the level ofsaid first groove 101. The opening 103 is connected to said finalreception zone 105 by a laterally inclined groove 104. An axial shoulder106 is provided between said final reception zone 105 and said inclinedgroove 104. Therefore, when said actuating sleeve 11 returns from itsactuation position towards its second projected position, said head 112of the flexible tab 110 slides in said laterally inclined groove 104,laterally deforming said flexible tab 110. When said actuating sleeve 11reaches its second projected position, after use, said head 112 clips inor snaps under said axial shoulder 106, locking said actuating sleeve 11relative to said central body 1 and relative to the lower body 10. Fromthis locked position, said actuating sleeve can no longer be displacedin the direction of its actuation position, due to the stop formedbetween the head 112 of the flexible tab 110 and the axial shoulder 106.

FIGS. 4 to 8 represent the start position, that is, at the moment whenthe user will commence using the autoinjector. It is evident in thesefigures that the head 112 is arranged in said groove axial 101 of thecentral body 1. When the actuating sleeve 11 slides towards the interiorof the lower body 10, said head 112 of the flexible tab 110 will slideinside said groove 101 of the central body. When the head 112 reachesthe axial end of the first groove 101, said radial cam 102 willcooperate with said head 112. This radial cam 102 will therefore deformthe flexible tab 110, and especially its rod part 111, radially towardsthe interior in the direction of its longitudinal central axis.

FIGS. 9 to 12 illustrate the position in which the flexible tab 110 isradially deformed. As evident especially in FIG. 11, after this radialdeformation the head 112 of the flexible tab 110 will continue to moveaxially over an additional distance to reach said opening 103. Theactuating sleeve 11 reaches its actuation position, as shown in FIG. 13.

In this actuation position, the flexible tab 110 returns elastically toits radially non-deformed position. The head 112 of the flexible tab 110returns inside said opening 103, as is evident in FIG. 14.

The radial deformation of the flexible tab 110, necessary to move theactuating sleeve from its first projected position towards its actuationposition, generates some resistance. Combined with the compression forceof the spring 12, this resistance obliges the user to exert at leastsome predetermined force to perform displacement of the actuating sleeve11 inside the lower body 10. This avoids any risk of accidental orunwanted actuation after the cap 14 is removed. Actuation takes placeonly if the user exerts said predetermined force on the actuating sleeve11. This force threshold also creates some precompression in the hand ofthe user, the effect of which is that displacement of the actuatingsleeve 11 towards its actuation position is ensured when this thresholdis reached.

When the actuating sleeve 11 reaches its actuation position, that is, inthe position of FIGS. 13 to 16, the spring 12 of the actuating sleevehas been compressed and the pricking lock is triggered by said actuatingsleeve 11, as will be described in more detail later, which causesdisplacement of the syringe A inside the lower body 10 and thereforepricking of the needle in the body of the user. Throughout this prickingphase and during the injection phase which follows said pricking phase,the actuating sleeve 11 does not move relative to the lower body 10,since the user maintains his pressure on the part of the body in whichhe is injecting.

At the end of use, when the user is going to remove the autoinjectorfrom his body, the spring 12 of the actuating sleeve 11 will stress saidactuating sleeve 11 to return from its actuation position towards itssecond projected position, as is shown in FIG. 3c . During this axialreturn deformation of the actuating sleeve 11 in the lower body 10, thehead 112 of the flexible tab 110 will cooperate with the inclined groove104 as is evident in FIGS. 17 and 18. This will cause elasticdeformation of the flexible tab 110, and especially of its rod part 111,to the extent where the actuating sleeve 11 will slide axially, the head112 sliding in said inclined groove 104 laterally deforming saidflexible tab 110 as clearly evident in FIG. 17. This inclined groove 104terminates in a final reception zone 105 provided with an axial shoulder106. At the end of the return path of the actuating sleeve 11, the head112 of the flexible tab 110 will penetrate this final reception zone 105and the upper edge 114 of the head 112 will cooperate with the axialshoulder 106, which will block the actuating sleeve 11 relative to thelower body 10. The actuating sleeve 11 can no longer slide axiallytowards the interior of the lower body 10, and the safety device is thenin the final locked position. Therefore, the needle is fully protectedafter use and the user can no longer utilise the autoinjector or injurehimself with the needle.

Of course, the forms of the grooves, their dimensions and theirinclinations can be modified as a function of the preferred needs andcharacteristics for the needle safety device.

The actuating sleeve described hereinabove is particularly effective andreliable, and is robust and easy and therefore inexpensive to mould.

FIGS. 32 to 46 describe more particularly the device for displacement ofthe syringe in the lower body 10. This device for displacement ensureson the one hand the pricking, that is, insertion of the needle in thebody of the user, and on the other hand retraction of the needle afterinjection.

As seen previously, at the start of actuation, the syringe A isdisplaced axially in said lower body 10 to perform insertion of theneedle in the body of the user. After injection of the fluid product inthe body of the user, and optionally after some delay provided by theretarding device described hereinabove, the syringe A is again displacedin the other direction inside the lower body 10 to be retracted andautomatically withdraw the needle from the body of the user. In thisway, when the user removes the autoinjector from his body, the needle nolonger projects but instead is retracted inside said autoinjector.

To perform these reciprocal displacements of the syringe A in the lowerbody 10, a control ring 2 is provided which cooperates with the controlsleeve 4, with the control slide 9 and with the actuating sleeve 11. Inaddition, the trigger 19 intervenes to perform retraction of the syringeinside the body, as will be explained hereinbelow.

FIGS. 33 to 35 illustrate the start position before the syringe isdisplaced for pricking. It is noted that the control ring 2 is stressedin rotation by the pricking spring 3, which here is a spring acting intorsion. Such a torsion spring performs painless pricking.

In this initial position of FIGS. 33 to 35, rotation of the control ring2 is prevented by a projection 91 of the control slide 9, as is moreclearly evident in FIG. 35.

When the actuating sleeve 11 arrives in its end position inside thelower body 10, as shown in FIG. 3b , a shoulder 118 of said actuatingsleeve 11 will cooperate with a shoulder 92 of the control slide 9 toaxially move said control slide 9 upwards in FIG. 36. This axialdeformation of the control slide 9 will release the rotation of thecontrol ring 2 which will be able to turn under the effect of its loadedpricking spring 3.

The control ring 2 comprises three inclined profiles 24, 25, 26 similarto ramps, whereof the functions will be explained hereinbelow.

The control ring 2 comprises a first inclined internal profile 24, suchas a, which will cooperate with a projection 44 of the control sleeve 4.Therefore, rotation of the ring 2 will progressively axially move saidcontrol sleeve 4. This control sleeve 4 cooperates with the syringehousing 13 which receives the syringe, and displacement of the controlsleeve moves the syringe A in the lower body 10 to perform pricking ofthe needle.

FIG. 39 illustrates the position in which the needle is fully inserted,with the first inclined profile 24 which cooperates with the projection44 of the control sleeve 4.

During displacement of the control sleeve 4 and therefore insertion ofthe needle into the body of the user, the projection 91 of the controlslide is also in contact with an external inclined profile 25 of thering 2, such as an external ramp, which will cause added axialdeformation of said control slide 9 relative to the actuating sleeve 11.This will displace the control slide 9 in the same direction as theactuating sleeve 11 during pricking. Because of this, the projection 92of the control slide 9 comes close to an upper projection 119 of theactuating sleeve 11, and the projection 95 of the control slide 9 comesclose to a projection 191 of the trigger 19, as is evident in FIG. 44.

The first internal inclined ramp 24 which cooperates with the projection44 of the control sleeve 4 advantageously comprises a flat section 241,that is, a non-inclined portion, evident in FIG. 41. This flat section241 has a very important function since it ensures that the start of theinjection will occur only after the total end of insertion of the needleinto the body of the user. Whereas for many autoinjectors it isnecessary to commence the injection slightly before the needle reachesits final insertion point, for reasons of manufacturing tolerance theflat section 241 on the ramp 24 avoids this phenomenon. In fact, whilethe ring 2 has already completely displaced the control sleeve 4 axiallyand therefore has completed total insertion of the needle of the syringein the body of the user, it is necessary for the ring 2 to turn furtheron the arc of a circle formed by said flat section, for example around30°, to trigger the injection lock. Therefore, the blocking ring 23 ofthe injection lock is displaced from its blocking position only afterthe extra rotation of the ring 2 on the arc of a circle formed by saidflat section 241. During this extra rotation, there is no axialdeformation of the control sleeve 4, and therefore of the syringe A,since the flat section 241 is not inclined. Even with manufacturingtolerances, this guarantees that insertion is finished before injectioncommences. In line with this, during this extra rotation of the controlring 2 a second internal inclined profile 26, such as a ramp, of thecontrol ring 2 will cooperate with a projection 235 of the blocking ring23 of the injection lock and displace the latter from its blockingposition to release the injection, when the control ring 2 arrives atthe end of its extra rotation. This is also evident in FIG. 41.Advantageously, the control ring 2 comprises three second internalinclined profiles 26 arranged at 120° to each other, and the blockingring 23 comprises three projections 235 also arranged at 120° to eachother, a respective projection 235 cooperating with a respective secondinternal inclined profile 26.

When the injection is triggered by the blocking ring 23, the rotation ofthe control ring 2 is again blocked by the control slide 9.

With the control slide 9 in the position of FIG. 44, if the user removesthe autoinjector from his body while the injection is underway or afterinjection but before the end of the retarder, the spring 12 of theactuating sleeve 11 will stress said actuating sleeve 11 returning fromthe lower body 10. This displacement of the actuating sleeve 11 willdraw the control slide 9 axially downwards in FIG. 44 by cooperationbetween the upper shoulder 119 and the projection 92 of the slider.Therefore, the control ring 2 will again be released in rotation by thecontrol slide 9, and the spring 3 will stress this control ring more inrotation, which will cause retraction of the syringe and of the needleinside the body. The actuating sleeve 11, on completion of movement,will be locked as described previously. Therefore, even if the userremoves the autoinjector before full distribution of the product, theneedle safety device is operative.

In normal operation, the injection is terminated and as will bedescribed hereinbelow the piston rod 5 will release the rotation of atrigger 19, optionally with some delay if a retarding device is used.From the moment when the trigger 19 has performed predefined rotation, aprojection 191 of the trigger 19 will cooperate with the upper shoulder95 of the control slide 9, and this control slide 9 will be displacedaxially downwards in FIG. 44, which will release rotation of the controlring 2, as described previously.

FIGS. 45 and 46 illustrate retraction of the needle with rotation of thering 2 which will bring the projection 44 of the control sleeve oppositean internal groove of the ring 2, which will cause, under the effect ofthe spring, axial return deformation of the control sleeve 4 inside thecontrol ring 2 and therefore retraction of the syringe and of theneedle.

FIGS. 19 to 26 schematically illustrate an advantageous injection lock.The autoinjector comprises injection means, comprising especially thepiston rod 5, the injection spring 8 and the blocking ring 23, theseinjection means being blocked in a loaded position by said injectionlock. The unblocking of said injection lock then causes actuation ofsaid injection means and therefore injection of the fluid productthrough the needle.

As shown in FIG. 19, said injection lock comprises a control sleeve 4arranged in said central body 1, said control sleeve 4 containing saidpiston rod 5 and said injection spring 8, said piston rod 5 comprising aradial recess 50 receiving at least one blocking element 7 mobilebetween a blocking position and an unblocking position. Said at leastone blocking element 7 is preferably substantially spherical in shape.In the variant shown, there are three blocking elements 7 in the form ofballs, but a different number of blocking elements and forms slightlydifferent to these blocking elements are possible. The followingdescription will be made however in reference to three balls, withoutthis being limiting. Said balls 7 are stressed radially towards theexterior by said piston rod 5 and are held in the blocking position by ablocking member, which in this embodiment is formed by a blocking ring23. This blocking ring 23 is displaceable axially relative to saidpiston rod 5 between a locking position, in which if keeps the blockingelements 1007 in the blocking position, and an unlocking position, inwhich said blocking elements 1007 are released to unblock said injectionlock, allowing said injection spring to displace said piston rod 5towards its injection position.

FIG. 20 shows the injection lock in the blocking position. The injectionspring 8 cooperates on the one hand with the piston rod 5 and on theother hand with a pellet support 6. This pellet support 6 is formed by aring arranged around said piston rod 5. The piston rod 5 comprises aperipheral recess 50, provided advantageously with an inclined surface51, formed by narrowing of the diameter of said piston rod 5. Thispiston rod 5 is arranged inside the control body 4 and is likely to bedisplaced axially towards the left in FIG. 20 to push the piston of thesyringe A inside the syringe and distribute the fluid product containedin said syringe through the needle.

As evident in FIG. 20, the balls 7 are arranged in said recess 50 formedin the piston rod 5 and cooperate therefore on the one hand with theinclined wall 51 of the piston rod 5 and on the other hand with theupper surface 61 of said pellet support 6.

The inclined surface 51 of the piston rod is in contact with the balls 7such that under the effect of the compressed spring 8, said inclinedsurface 51 exerts a reaction force F1 on the balls 7, this force F1 notbeing exactly axial but directed slightly towards the exterior,stressing the balls 7 radially towards the exterior of the blockingposition of FIG. 20.

The blocking ring 23 is provided radially outside the balls 7 toradially block said balls in the blocking position. In reference moreparticularly to FIG. 22, it is evident that the balls can be arranged inhousings of the control sleeve 4, the blocking ring 23 comprisingprojections 231, one for each ball 7, which are positioned in contactwith the balls 7 to prevent the latter from being displaced radiallytowards the exterior.

The pellet 6 transmits the force F3 of the spring 8 to the balls 7, andthe blocking ring 23 exerts a reaction force F2 on the balls 7 toprevent radial displacement of the latter. Therefore, it is the balls 7which support all the forces exerted on the lock in the blockingposition, with balance at three points under the effect of forces F1, F2and F3. Such a lock is particularly stable and robust and especiallyresists drops tests. These tests simulate the fact of dropping theautoinjector to the floor after the cap 14 has been removed, the aimbeing to avoid triggering of the injection lock during this fall. Inparticular, no force is exerted on the structural pieces of theautoinjector, such as the central body 1 or the lower body 10. This lockaccordingly avoids the risk of untimely disassembly of the device duringtransport or handling.

It is evident that the balls 7 could be replaced by non-sphericalelements but of rounded more complex shape, for example in the form of acylinder or bean, to further improve the stability of the lock. In thiscase, these non-spherical mobile elements could be made of metal, forexample by steel wire cutting.

When the needle of the syringe has fully penetrated the body of theuser, and only after this total insertion, as will be described later,the blocking ring 23 is displaced according to arrow E1 in FIG. 21. Theeffect of this is to release the balls 7 from their blocking position,the latter being displaced radially towards the exterior according toarrow E2. As a variant, the blocking ring 23 could also be displaced inrotation towards a position where it releases the balls. The pelletsupport 6 then stops against an internal edge of the control sleeve 4,as shown by arrow E3 in FIG. 21. In this position, the piston rod 5 isno longer held by the balls 7 and it is therefore displaced axially,that is, towards the left in FIG. 21, to perform injection of theproduct. The balls 7 can no longer return to the blocking position,prevented by the pellet 6, as is evident in FIG. 21.

With slightly different views FIGS. 23 to 26 illustrate the twopositions of blocking and unblocking of the injection lock, as describedhereinabove in reference to FIGS. 20 and 21.

The injection lock shown in FIGS. 19 to 26 unlocks a substantial forceexerted by a compressed spring, in this case the injection spring 8, byexerting a relatively weak and easily controlled force on the blockingring 23. In particular, the force necessary to move said blocking ring23 into the unblocking position can represent only 10%, or even only 5%,of the force exerted by the injection spring 8. This represents a verylarge yield which ensures easy and reliable actuation of the device.

When the injection is finished, that is, when the piston rod 5 hasreached its end position in which the piston of the syringe A has beendisplaced to inject the fluid product, a trigger 19 is actuated toretract the syringe and therefore the needle.

During the injection phase, a locking finger 20 extends through thetrigger 19 and into the central channel 151 of the upper body 15. Aretardant spring 18, here a spiral spring, stresses said trigger 19 inrotation. This rotation is blocked by the locking finger 20,advantageously oblong in shape, which is adapted to turn together withsaid trigger 19, but which is blocked in rotation by said centralchannel 151 of the upper body 15. During the injection phase, the pistonrod 5 moves axially, that is, towards the left in FIG. 28. As it moves,it will pull on the wire 21 which will therefore extend out of thechannel 151. As the locking finger 20 is arranged inside the centralchannel 151, rotation of the trigger 19 is blocked. When the piston rod5 approaches the end of the injection path, the wire 21 is completelytaut and held between the piston rod 5 and the locking finger 20, andany extra displacement of the piston rod 5 will therefore axiallydisplace the locking finger 20 out of said central channel 151. When thepiston rod 5 reaches the end position of the end of injection, thelocking finger stops cooperating with the central channel 151, and thetrigger 19 and the locking finger can turn under the effect of theretardant spring 18. As evident in FIG. 31, the trigger 19 comprises anexternal inclined ramp 190 which can comprise a projection 191 to oneside. When the trigger 19 will have described a predefined rotation,typically about one turn, this projection 191 will cooperate with thecontrol slide 9, which will displace the latter axially and triggerretraction of the needle, as has been described previously.

FIGS. 27 to 31 illustrate an advantageous retarding device.

The main aim of this retarding device, which is optional in anautoinjector, is to offset retraction of the syringe A in time andtherefore of the needle out of the body of the user after completion ofinjection of the fluid product inside said body. This especially enablesdiffusion for a few seconds of the product after its injection. Such aretarder also produces a benefit for the user who no longer has tocount, for example up to 10, after injection, the time taken for thiscounting varying widely from one user to another. A retarder makes thesequence of use of an autoinjector easy.

The mechanical retarder shown in FIGS. 27 to 31 offsets this retractionby a few seconds, this delay being predeterminable.

FIG. 27 illustrates an exploded schematic view of this retarding device.This comprises the upper body 15, several planetaries 16 with severalsatellites 17, the retardant spring 18, the trigger 19, the lockingfinger 20, the wire 21 and the piston rod 5. It is this piston rod 5which will perform actuation of the retarding device when it arrives atthe end of the injection path with all the product which has beeninjected.

FIG. 28 shows the retarding device before its actuation. It is evidentthat the actuation rod 5 is connected to the locking finger 20 by meansof the wire 21. In this position, the wire 21 and the locking finger 20extend inside a central channel 151 of the upper body 15 and into thetrigger 19. The upper body 15 comprises a gear 155 on its lateralinternal surface, as clearly evident in FIG. 30. This internal gear 155of the upper body 15 cooperates with a plurality of satellites 17 whichare assembled on planetaries 16. In the example shown in FIG. 28, thereare several planetaries stacked axially on each other. The planetaries16 comprise a plate in the form of a disc on which are formed to oneside satellite support rods 161 which each rotatively receive asatellite 17. In the example shown, there are three satellites 17 toeach stage such that there are three rods 161. Each planetary 16associated with its satellites 17 forms one stage of the retardingdevice. On the other side of the plate in the form of a disc theplanetary 16 comprises a gear 162 adapted to cooperate with thesatellites 17 of the adjacent stage. Therefore, as is evident in FIG.30, the retarding device utilises the principle of epicycloidal trains.Each stage of this device demultiplies and/or slows down the rotationsof the previous stage.

When a retarding device is used, the trigger 19 cooperates with a firstplanetary 16, whereof the rods 161 extend inside said trigger 19. Thegear 162 of this first planetary 16 cooperates with the satellites of asecond adjacent planetary, which cooperate with the lateral gear 155 ofthe upper body 15, demultiplying the rotation of the first planetary andtherefore of the trigger, and therefore braking this rotation. Eachadditional stage of the epicycloidal train forming the retarder willfurther demultiply these rotations, and therefore further brake therotation of the trigger 19. Therefore, with four stages as shown in thefigures, the rotation of the trigger 19 can be made as a single turn,whereas the last planetary 16 arranged at the very bottom of the upperbody 15 will describe around fifty turns simultaneously.

According to the number of stages and/or according to the number ofsatellites and/or according to the form of the planetaries and/oraccording to the dimensions of the gears in play, the delay between themoment when the retarding device is triggered and the moment when thetrigger 19 will have performed its predefined rotation to triggerretraction of the syringe can be adjusted fairly precisely, as will beexplained later. Friction braking can also be provided, for examplebetween the satellites 17 and the internal gear 155 of the upper body15.

The retarding device therefore offsets the moment when said trigger willactuate retraction of the needle by a predetermined time, from themoment when the injection phase is finished.

It is evident that the deployable wire principle connected on the onehand to the piston rod 5 and on the other hand to the locking finger 20can be used without the train epicycloidal system such as shown in FIGS.27 to 31, as will be especially described hereinbelow in reference tothe second embodiment. This wire, of minimal bulk, ensures thatretraction of the needle commences only once the injection phase isfully finished, especially compensating any manufacturing tolerances.More generally, the use of a wire reduces the bulk of the device.Because of this, it can be used advantageously for various functions inan autoinjector, as there is a need to pull one piece relative toanother.

According to an advantageous aspect, the external shell 22 comprisesseveral indicators which inform the user of the advance of sequences forpricking, injection and retraction. In case of use of a retardingdevice, display of said delay can also be provided.

Therefore, as evident in FIGS. 2a to 2f , the external shell 22 cancomprise several display windows, in this case three windows 221, 222,223, which display mobile elements during different phases of actuation,these elements comprising indicators, typically colours.

Therefore, the control slide 9, which at rest is in a first positionrelative to the central body 1, moves axially towards a second positionduring displacement of the actuating sleeve 11. It remains in thissecond position throughout the injection phase, and returns in thedirection of its first position during retraction of the needle. It isonly when the actuating sleeve returns to its second projected positionthat the control slide reaches this first position. This control slide 9can comprise one or more colour indicators, for example a red zone asevident in FIG. 1. This slider can therefore be used to indicate on theone hand the projected position of the actuating sleeve 11 (firstposition) and on the other hand the pricking and injection phase (secondposition).

The trigger 19, which triggers the retraction of the needle oncompletion of injection, can also comprise an indicator, for example ared zone which displays when said trigger has performed its predefinedrotation and actuated retraction of the needle.

Therefore, the first display window 221 can be the window for completionof injection, that is, when a predefined colour, red for example,appears in the window 221, the injection is finished and the syringe hasbeen retracted. The user therefore knows that when this first displaywindow is red he can remove the autoinjector from his body in completesafety. This indication can be supplied for example by the trigger 19.

The second display window 222 can be that of the phases of pricking andinjection, which changes to red at the start of the pricking phase atthe end of the injection phase. This prevents the user from removing theautoinjector from his body during these phases, which can last severalseconds. This indication can be supplied by the actuator slider 9.

The third display window 223 can be that of the actuating sleeve 11,with the red displayed when the actuating sleeve 11 is in a projectedposition out of the lower body. This third display window 223 istherefore red prior to actuation, then again after use when theactuating sleeve 11 is locked in the safety position. This indicationcan be supplied by the control slide 9. In the example shown, the redzone of the actuator slider 9 moves from the third display window 223,prior to actuation (FIG. 2a ), to the second display window 222 (FIG. 2c) when the actuating sleeve is in the actuation position where ittriggers the pricking phase. During this transition, said red zone isnot evident as it is located between said windows 223 and 222 (FIG. 2b). During the phases of pricking and injection, the control slide staysin its second position (FIG. 2c & FIG. 2d ). When the control slide 9 isagain displaced axially towards its first position by the trigger 19, toactuate retraction of the needle, the red zone changes back from thesecond window 222 to the third window 223, being invisible again (FIG.2e ), to finally reappear in the third window 223 when the actuatingsleeve is locked in the second projected position (FIG. 2f ).

In this configuration, the combination of red in the first and thirddisplay windows 221 and 223 ensures the end of the process of use of theautoinjector, with the needle retracted and the actuating sleeve 11locked, ensuring optimal safety.

Of course, other means of display or indication are also possible andsaid external shell 22 can comprise any number of display windows, ofany form and dimension, and which could be positioned differently to thevariant shown in the figures. The same window can especially displayseveral different functions.

Optionally, in the first display window 221 or in another displaywindow, for example an additional display window, the state of theretarding device can be displayed, for example with a count. This couldbe done for example with numerical values inscribed on the lateralexternal edge of the trigger which moves progressively into anappropriate display window and which in seconds displays the count ofthe retarder. Other variants are of course also possible.

This external shell 22 can also comprise a button or buttons forpricking and/or retraction of the needle if the autoinjector providessuch buttons to perform pricking and/or retraction of the needle.

The external shell 22 could also comprise a temperature indicator of theproduct to be injected. In fact, many products to be injected are storedat 8° and it is often recommended to bring them out 30-60 minutes inadvance. If the product is too cold at the moment of the injection, thiscan cause pain for the patient. For example, the shell 22 could comprisetemperature display of the reservoir containing the product to beinjected. As a variant, a label could also be provided which changescolour with temperature. This temperature indicator could be provided onthe shell, or on the reservoir, especially the syringe, and be visiblethrough a window of the shell.

FIGS. 47 to 74 c illustrate several variants of a second embodiment ofthe invention. This second embodiment relates to a simplifiedautoinjector, comprising fewer pieces, and therefore simpler and lesscostly to make and assemble.

In the variant of FIG. 47 of this second embodiment, the autoinjectorcomprises a lower body 1010, an actuating sleeve 1011, a spring 1012 ofthe actuating sleeve, a cap 1014, a control sleeve 1004, a piston rod1005, a pellet support 1006, three blocking elements 1007, here in theform of balls, an injection spring 1008, a click member 1500, a wire1021, and an external shell 1022.

The cap 1014 especially locks the autoinjector during transport andstorage. As this cap is installed on the lower body 1010, it preventsany actuation of the actuating sleeve 1011 and therefore any triggeringof the autoinjector.

As for the first embodiment, the syringe A is a pre-filled syringe. Itcomprises advantageously a needle cap B which protects and isolates theneedle prior to use of the autoinjector. Advantageously, this needle capB is removed automatically at the moment when the cap 1014 is removedfrom the lower body 1010.

It is evident that this second embodiment has several elements similarto the first embodiment, these similar elements being designated byreference numerals similar to those of the first embodiment, augmentedby 1000. Therefore, for example, the actuating sleeve reference 11 inthe first embodiment is now reference 1011. Consequently, in thedescription of this second embodiment, it is mainly the differencesrelative to the first embodiment which will be described, given that theother elements and functions remain similar, if not identical, betweenthe two embodiments.

The principal difference in this second embodiment is that thereservoir, in this case the syringe A, is fixed relative to the lowerbody 1010, relative to the control sleeve 1004 and relative to theexternal shell 1022. Therefore, to perform pricking of the needle onlythe actuating sleeve slides relative to the rest of the autoinjector. Inthis second embodiment there is therefore no device for syringedisplacement.

FIGS. 48a to 48e illustrate the sequences of the use of the autoinjectorof FIG. 47.

In FIG. 48a , the autoinjector is in a rest position prior to use, thecap 1014 having been removed.

When the user wants to use the autoinjector, he takes the device, forexample at the level of the external shell 1022 and presses theactuating sleeve 1011, which in a first projected position projects outof the lower body 1010, against the part of the body where he wants toperform the injection. In FIG. 48b , it is evident that the pressureexerted by the user on the actuating sleeve 1011 causes sliding of thelatter towards the interior of the lower body 1010, which reveals theneedle and therefore its pricking due to the pressure exerted by theuser on the autoinjector.

When the actuating sleeve 1011 reaches its actuation position, which isits end position inside the lower body 1010, it causes triggering of theinjection phase which is shown in FIGS. 48c and 48d . It is noted thatthe piston rod 1005 slides inside the syringe A by pushing the piston ofthe latter under the effect of the injection spring 1008. The product istherefore distributed.

On completion of the injection, when the user removes the autoinjectorfrom the injection site, the actuating sleeve 1011 is again shifted outof the lower body 1010 towards a second projected position, under theeffect of the spring of the actuating sleeve, with locking of saidactuating sleeve 1011, which ensures absolute safety for the user andavoids any risk of injury with the needle after use of the device. It isevident that the first and second projected positions of the actuatingsleeve, which, in the example shown, are different positions, couldoptionally be identical.

In this second embodiment, as evident especially in FIGS. 49a to 52,said actuating sleeve 1011 also comprises a flexible tab 1110 which isflexible laterally only, that is, it deforms in the direction peripheralof the actuating sleeve 1011 only. An actuating sleeve 1011 providedwith such a flexible tab is even simpler to mould than the flexible tabwith double flexibility of the first embodiment, which is favourablefrom the point of view of manufacturing costs. With a tab flexiblelaterally only, there is also a gain in radial bulk, which especiallyimproves the aesthetics of the autoinjector. The flexible tab 1110advantageously comprises a rod part 1111 which is flexible and whichterminates in a head part 1112.

In a first variant, illustrated in FIG. 51, said flexible tab 1110 isadapted to deform laterally relative to said lower body 1010 on the onehand when said actuating sleeve 1011 is displaced from its firstprojected position towards its actuation position and on the other handwhen said actuating sleeve 1011 is displaced from its return actuationposition towards its second projected position. In this case, the head1112 of the flexible tab must overcome resistance to deform laterally atthe start of the actuation, to create a sort of precompression whichensures that when the actuating sleeve will slide towards the interiorof the lower body 1010, the needle will suddenly penetrate the injectionsite as far as its planned injection position. In the example of FIG.51, this resistance is formed by a shoulder 1019 of the lower body 1010.

Preferably however, in a second variant shown in FIGS. 50 a, b, c and52, said flexible tab 1110 is not deformed when said actuating sleeve1011 is moved from its first projected position, prior to actuation,towards its actuation position, and said flexible tab is deformedlaterally only when said actuating sleeve 1011 is moved from itsactuation position towards its second projected position, at the end ofuse. In this variant, prior to actuation, the actuating sleeve 1011 isconnected to said lower body 1010 by at least one breakable bridge 1500.This embodiment especially allows easy moulding, and therefore reducedmanufacturing costs, adaptation and management of the breaking force ofthe breakable bridges facilitated by the dimensioning of these bridges,and an evidence of use function.

FIG. 52 illustrates two breakable bridges 1500, adapted to break andtherefore enable sliding of the actuating sleeve 1011 relative to thelower body 1010 when the user presses the autoinjector on the injectionsite using predetermined pressure.

When the actuating sleeve 1011 returns from its second actuationposition towards its projected position, under the effect of the spring1012, when the user removes the autoinjector from the injection site,the operation of the flexible tab 1110 can be identical to thatdescribed within the scope of the first embodiment, with an inclinedgroove, a final reception zone and an axial shoulder cooperating withthe head of the flexible tab to block it in the second projectedposition.

In a variant, the lower body 1010 can comprise a shoulder 1019 whichextends axially towards the interior by a ramp 1018, for example formedby a groove, which is at least partially inclined. Therefore, when theactuating sleeve 1011 returns from its actuation position towards itssecond projected position the head 1112 of the flexible tab 1110 will bedeformed laterally by said ramp 1018, to finally returns to clip in orsnap under the projection 1019 in the second projected position to blockthe actuating sleeve.

In the variant of FIG. 51, this same projection 1019 can cooperate withthe head 1112 of the flexible tab 1110 at the same time at the start ofactuation to create precompression and at the end of actuation to blockthe actuating sleeve in the second projected position. Of course, twodifferent shoulders can also be provided to carry out these twofunctions.

It is evident that the flexible tab 1110 can be fixed to said actuatingsleeve 1011 only at the level of its rod part 1111, with in this casethe head 1112 forming a free end of said flexible tab. By way ofvariant, the flexible tab could also be fixed to said actuating sleeveon two sides, with the head 1112 arranged between the two fasteningpoints. This execution reinforces especially the robustness of theflexible tab. This variant could also be adapted to the flexible tab ofthe first embodiment.

In the variants of FIGS. 49a to 52, the flexible tab 1110 of theactuating sleeve 1011 cooperates advantageously with an opening 103, aninclined groove 104, a final reception zone 105 and an axial shoulder106 of the body 1010 which are similar to these same elements describedpreviously in reference to FIGS. 4 to 18.

FIGS. 72 to 74 c illustrate another variant embodiment of the actuatingsleeve. In this variant, the reference numerals will be similar to thosehereinabove, but augmented by 1000. Therefore for example, the actuatingsleeve will be referenced 2011. In this particular variant, thefunctions of the actuating sleeve 2011 and of the body 2010 arereversed, the body 2010 comprising the flexible tab 2110, and theactuating sleeve 2011 comprising the profile which will cooperate withsaid flexible tab 2110. The operation however remains similar to thatdescribed previously, with the flexible tab 2110 which willprogressively slide in said profile, and especially in an inclinedgroove 2104 which connects an opening 2103 to a final reception zone2105. To lock the device at the end of actuation in the final receptionzone 2105, the flexible tab 2110 will clip or snap onto the shoulder2106, as is evident in FIG. 74c . As described previously, the flexibletab must advantageously overcome resistance to deform at the start ofthe actuation to create a sort of precompression which ensures that whenthe actuating sleeve 2011 will slide towards the interior of the lowerbody 2010 the needle will suddenly penetrate the injection site as faras its planned injection position. In the example of FIGS. 72 to 74C,this resistance is formed by a shoulder 2019 of the actuating sleeve2011. It is evident that the flexible tab 2110 can be formed monobloc onthe body 2010, or as a variant be formed on a separate piece assembledon said body 2010, for example for reasons of simplicity and/ormoulding.

FIGS. 53a, b , 54 a, b, 57 a, b, c and 58 a, b, c illustrate adaptationto the second embodiment of the injection lock described in the firstembodiment.

As described previously, the autoinjector comprises injection means,comprising especially the piston rod 1005 and the injection spring 1008,these injection means being blocked in a loaded position by saidinjection lock. The unblocking of said injection lock causes actuationof said injection means and therefore injection of the fluid productthrough the needle.

As shown in the different FIGS. 53, 54, 57 and 58 said injection lockcomprises a control sleeve 1004 arranged in said external shell 1022,said control sleeve 1004 containing said piston rod 1005, said injectionspring 1008 and a pellet support 1006. In the blocking position shown inthe different FIGS. 53 and 57, the injection spring 1008 cooperates onthe one hand with the piston rod 1005 and on the other hand with saidpellet support 1006. This pellet support 1006 is formed by a ringarranged around said piston rod 1005. Said piston rod 1005 comprises atleast one radial recess 1050 receiving at least one blocking element1007 mobile between a blocking position and an unblocking position.Advantageously, there are three blocking elements 1007, preferablysubstantially spherical in shape, especially in the form of balls, but adifferent number of blocking elements and rounded forms different tothese blocking elements are possible. Said blocking elements 1007 arestressed radially towards the exterior by said piston rod 1005 and areheld in the blocking position by a blocking member, which in this secondembodiment is formed by said control sleeve 1004. This control sleeve1004 is displaceable axially relative to said piston rod 1005 between alocking position in which it holds the blocking elements 1007 in theblocking position, and an unlocking position in which said blockingelements 1007 are released to unblock said injection lock, allowing saidinjection spring to displace said piston rod 1005 towards its injectionposition.

As evident more particularly in FIGS. 57a and 58a , the control sleeve1004 comprises one or more windows 1400 which allow the blockingelements 1007 to move when the control sleeve has been displaced towardsits unlocking position, shown especially in FIG. 58. The displacement ofthe control sleeve 1004 from its locking position towards its unlockingposition is performed by a projection 1411 of the actuating sleeve 1011,which will cooperate with a shoulder 1410 of the control sleeve 1004such that the control sleeve 1004 is in the unlocking position when theactuating sleeve 1011 is in the actuation position. Since said pistonrod 1005 is now not blocked by said blocking elements 1007, it isdisplaced out of the control sleeve by said precompressed injectionspring 1008 to move the piston into the reservoir and inject productthrough the needle. This type of lock enables unblocking with littleeffort, ensuring sound and tactile comfort for the user duringinjection.

Advantageously, the autoinjector comprises a sound and/or tactileindication device 1500 to indicate by an audible or by a tactileindication to the user that the injection phase is finished. This devicewill be described hereinbelow in relation to three variants of thesecond embodiment, but it could also be adapted to an autoinjector madeaccording to the first embodiment.

According to a first variant embodiment, this sound and/or tactileindication device 1500 comprises a central piece 1501 provided with atleast one lateral piece 1502 connected to said central piece 1501 by apliable and/or breakable link 1503. In the example shown in FIGS. 55 to59 c, there are two lateral pieces 1502, each connected to the centralpiece by a breakable link.

The central piece 1501 is connected to said piston rod 1005 by said wire1021, which is fixed on the one hand to said central piece 1501 and onthe other hand to said piston rod 1005. In the blocking position of theinjection lock, before the start of the injection, the wire 1021 iswound around the piston rod and the central piece 1501 is arrangedoutside the control sleeve 1004. When the control sleeve 1004 isdisplaced towards its unlocking position, shown especially in FIG. 58a ,an upper edge of said control sleeve 1004 makes contact with saidlateral pieces 1502. During the injection, when the piston rod 1005moves relative to the control sleeve 1004, the wire 1021 willprogressively unwind until it is stretched on completion of injection,as shown in FIG. 58b . From this moment, the wire 1021 will exerttraction on the central piece 1501, under the effect of the reaction ofthe upper edge of the control sleeve 1004 causing displacement and/ordeformation of the lateral pieces. In the example shown with breakablelinks 1503, the latter break, allowing the lateral pieces 1502 to moveabove the central piece 1501, and therefore the control sleeve 1004 tomove axially relative to the external shell 1022, as evident especiallyin FIG. 59a . As this displacement happens under the pressure exerted bythe injection spring 1008 on the control sleeve 1004, it is relativelybrusque and creates a shock between the control sleeve 1004, the lateralpieces 1502 and/or the external shell 1022. This shock is audible and/ortactile for the user who therefore receives information on thecompletion of injection. After actuation of this sound and/or tactileindication device, the wire 1021 is no longer fully stretched, asillustrated schematically in FIGS. 59a and 59 b.

FIGS. 60 to 64 c illustrate a second variant of the sound and/or tactileindication device. In this second variant, the central piece is omitted.The sound and/or tactile indication device 1500 comprises a mobileelement which is here formed by the control sleeve 1004, which comprisesat its distal end relative to the needle one or more deformable feet1510, which on completion of injection will stop against the externalshell 1022. This control sleeve 1004 is in a first position relative tothe external shell 1022 prior to actuation of the autoinjector, as shownin FIG. 64a . During actuation, the opening of the injection lock, andtherefore the start of the injection phase, causes displacement of thecontrol sleeve 1004 towards a second position, evident in FIG. 64B. Herea central piece called a key 1120 advantageously replaces the wire ofthe preceding first variant. This key 1120, especially evident in FIGS.63a and 63b , comprises a rod part 1121 which extends inside the pistonrod 1005, this rod part being similar to the wire of the first variant.The key 1120 also comprises a head part 1122, arranged at the upper end(or distal end relative to the needle) of said key. This head partcooperates with said deformable feet 1510 of the control sleeve 1004 toprevent it from deforming radially towards the interior. Because ofthis, these deformable feet 1510 block said control sleeve in its secondposition relative to said external shell 1022. The lower end (orproximal end relative to the needle) of the rod part 1121 cooperateswith the piston rod 1005 on completion of injection, causing sliding ofsaid key 1120 relative to the control sleeve 1004 and to the externalshell 1022. Therefore, after this sliding, the head part 1122 no longercooperates with the feet 1510 of the control sleeve, which can deformradially towards the interior. The effect of this is to unblock thecontrol sleeve 1004 which is then shifted towards a third positionagainst said external shell 1022 under the effect of the force exertedby the injection spring 1008. This creates an audible shock or otherwisedetectable by the user who now knows that the injection is finished.

Advantageously, the external shell 1022 comprises one or more,especially three, display windows 1023 in which said deformable feet1510 become visible at the same time as they tap against the externalshell. This allows visual indication simultaneously to the sound and/ortactile indication.

Advantageously, said at least one display window 1023 is formed on or inthe distal end edge of said external shell 1022, being visible at thesame time in the axial direction and in the radial direction of saidshell. This execution avoids masking the display window or the windows1023 when the autoinjector is handled by the user, ensuring properdisplay of information displayed in said at least one display window1023 throughout the phase of use, from start to finish. With severaldisplay windows 1023, especially three, distributed around the distalend edge of the body 1022, this ensures perfect display irrespective ofthe orientation of the autoinjector at the moment of its use.

The variant embodiments of the second embodiment of the autoinjectordescribed hereinabove therefore define a control sleeve 1004 havingthree different positions: prior to injection when it is in the lockingposition, during injection when it is in the unlocking position, andafter injection when it has actuated the sound and/or tactile indicationdevice. This easily displays these three distinct positions in asuitable display window 1221. Of course, the external shell 1022 of thissecond embodiment could also comprise several display windows, asdescribed in the first embodiment.

FIGS. 65 to 71 illustrate a third variant embodiment of the sound and/ortactile indication device. In this variant, which is similar to thesecond variant hereinabove, the mobile element of the sound and/ortactile indication device is not formed by the control sleeve 1004 butby the support pellet 1006 on which the injection spring 1008 issupported. FIGS. 66a and 66b shows this support pellet, which comprisesone or more deformable feet 1520, which are similar to the deformablefeet 1510 of the control sleeve 1004 of the second variant hereinabove.The operation is also similar, with the key 1120 which blocks by itshead 1122 the radial deformation of said feet 1520, which blocks thepellet support relative to the external shell. When the piston rod hasthe key 1120 slide on completion of injection, by traction on the rodpart 1121, the head part 1122 of the key 1120 will release said feet1520, which deform radially towards the interior and will allow saidpellet support 1006 to be projected against said external shell,creating a sound and/or tactile indication. Advantageously, as describedpreviously, a visual indication is also supplied by a display window orwindows 1023 of the external shell which show the deformable feet 1520of the pellet support 1006.

FIGS. 69 to 71 illustrate in more detail the operation of the soundand/or tactile indication device. In FIG. 69, the deformable tab 1520 isprevented from deforming radially towards the interior by the presenceof the head part 1122 of the key 1120. In FIG. 70, the key has beendisplaced by the piston rod and consequently the deformable tab 1520 hasdeformed radially towards the interior. This has caused displacement ofthe support pellet 1006 in the external shell, with a shoulder 1521 ofthe deformable tab which stops on a part of said external shell,generating the sound and/or tactile indication, for example an audibleor sensitive vibration. Simultaneously, the end of the deformable tab1520 has been positioned in the window 1023 of the external shell 1022,as is evident in FIG. 70. FIG. 71 illustrates the end of the injection,with the piston rod 1005 which will pull on the rod part 1121 of the key1120 to move the latter.

The present invention applies to devices used especially for treatmentof auto-immune diseases, for example of rhumatoid arthritis, multiplesclerosis, Crohn's disease type, for treatments against cancer, forantiviral treatment, for example of hepatitis type, for treatmentagainst diabetes, for treatments against anaemia or for treatment ofstress, for example in the event of anaphylactic shock.

Even though the present invention has been described in reference toseveral advantageous modes and variant embodiments, which combineseveral functional modules, it is understood that the different modulesdescribed can be used independently of each other. In particular, theactuating sleeve and/or the device for displacement of syringe forpricking and/or retraction and/or the injection lock and/or theretarding device and/or the sound and/or tactile indication device couldbe used independently of each other. Pricking of the needle and/orretraction of the needle after injection could be controlled by one ormore button(s). The sound and/or tactile indication device of the secondembodiment could be used with an autoinjector of the type described inthe first embodiment. Other modifications are also possible for theexpert without departing from the scope of the present invention such asdefined by the attached claims.

What is claimed is:
 1. An autoinjector comprising: a lower bodyreceiving a reservoir, said reservoir containing fluid product andcomprising a piston and a needle, said autoinjector comprising: anactuating sleeve provided with a contact end designed to make contactwith the body of the user, said actuating sleeve being displaceablebetween projected positions and an actuation position, said actuatingsleeve being in a first projected position prior to actuation of theautoinjector and in a second projected position after actuation of theautoinjector, injection means to inject said fluid product through saidneedle when said needle is in an injection position, said injectionmeans comprising a piston rod, a pellet support and an injection springcooperating on one side with said piston rod and on another side withsaid pellet support, said pellet support comprising at least onedeformable foot; an injection lock to block said injection means, saidactuating sleeve being configured to be automatically returned to saidsecond projected position when the user removes the autoinjector fromhis body, said actuating sleeve being locked in this second projectedposition, preventing any other actuation of the autoinjector, whereinsaid autoinjector comprises an external shell comprising one or moredisplay windows for indicating visually to the user actuation sequencesof the autoinjector, at least one of the one or more display windows forindicating to the user that the injection of the fluid product isfinished by showing through said at least one display window said atleast one deformable foot of said pellet support; and wherein one ofsaid one or more display windows is formed in a distal end edge of saidexternal shell and is visible at the same time in an axial direction andin a radial direction of said external shell.
 2. The autoinjectoraccording to claim 1, comprising a reservoir displacement device todisplace the needle towards an injection position in which the needle isinserted in the body of the user and to retract said needle out of thebody of the user after injection of the fluid product, said actuatingsleeve in the actuation position, actuating said reservoir displacementdevice to move the needle towards the injection position, said reservoirdisplacement device unblocking said injection lock and actuating theinjection means when the needle is in the injection position, in whichsaid injection means actuate said reservoir displacement device afterinjection of the fluid product to retract said needle.
 3. Theautoinjector according to claim 2, in which said reservoir displacementdevice comprises a control slide displaceable axially in saidautoinjector during the actuation, said control slide comprising atleast one indicator evident through at least one of said one or moredisplay windows.
 4. The autoinjector according to claim 3, wherein theat least one indicator is a colour zone.
 5. The autoinjector accordingto claim 2, in which said injection means actuate a trigger whichactuates the retraction of the needle after a predefined rotation, saidtrigger comprising at least one indicator evident through at least oneof said one or more display windows.
 6. The autoinjector according toclaim 5, wherein the at least one indicator is a colour zone.
 7. Theautoinjector according to claim 2, in which one of said one or moredisplay windows are configured to further indicate to the user that theneedle is in a retracted position.
 8. The autoinjector according toclaim 2, in which one of said one or more display windows are configuredto indicate to the user that the phases of pricking and injection of thefluid product are underway.
 9. The autoinjector according to claim 2, inwhich one of said one or more display windows are configured to indicateto the user that the actuating sleeve is in a projected position. 10.The autoinjector according to claim 2, comprising a retarding deviceadapted to retard during a predetermined time the actuation of saidreservoir displacement device by said injection means after injection ofthe fluid product, to delay retraction of said needle of saidpredetermined time after the end of the injection.
 11. The autoinjectoraccording to claim 10, in which one of said one or more display windowsare configured to indicate the flow of said predetermined time to theuser.
 12. The autoinjector according to claim 2, comprising a spring andan assembly of gears arranged to retard during a predetermined time theactuation of said reservoir displacement device by said injection meansafter injection of the fluid product, to delay retraction of said needleof said predetermined time after the end of the injection.
 13. Theautoinjector according to claim 1, comprising a control sleevedisplaceable axially relative to said external shell between a firstlocking position in which it locks the injection lock, and a secondunlocking position, in which it allows unblocking of the injection lockand therefore the injection of the product through the needle, saidcontrol sleeve being displaced from its locking position towards itsunlocking position by said actuating sleeve.
 14. The autoinjectoraccording to claim 13, in which said control sleeve is also displaceableaxially relative to said external shell between said second unlockingposition and a third final position, in which it has actuated a soundand/or tactile indication device to inform the user of the end ofinjection.
 15. The autoinjector according to claim 13, in which one ofsaid one or more display windows is adapted to indicate the differentaxial positions of said control sleeve.
 16. The autoinjector accordingto claim 1, wherein the piston and the needle are part of a pre-filledsyringe.
 17. The autoinjector according to claim 2, in which one or moredisplay windows said external shell comprises: a first display window ofsaid one or more display windows for indicating to the user both thatthe injection of the fluid product is finished and that the needle is ina retracted position; a second display window of said one or moredisplay windows for indicating to the user that the phases of prickingand injection of the fluid product are underway; and a third displaywindow of said one or more display windows for indicating to the userthat the actuating sleeve is in a projected position.
 18. Anautoinjector comprising a lower body receiving a reservoir, saidreservoir containing fluid product and comprising a piston and a needle,said autoinjector comprising: an actuating sleeve provided with acontact end designed to make contact with the body of the user, saidactuating sleeve being displaceable between projected positions and anactuation position, said actuating sleeve being in a first projectedposition prior to actuation of the autoinjector and in a secondprojected position after actuation of the autoinjector; injection meansto inject said fluid product through said needle when said needle is inan injection position; said injection means comprising a piston rod, apellet support and an injection spring cooperating on one side with saidpiston rod and on another side with said pellet support, said pelletsupport comprising at least one deformable foot; an injection lock toblock said injection means; said actuating sleeve being configured toautomatically return to said second projected position when the userremoves the autoinjector from his body, said actuating sleeve beinglocked in this second projected position, preventing any other actuationof the autoinjector; wherein said autoinjector comprises an externalshell comprising one or more display windows indicating visuallyactuation sequences of the autoinjector, at least one of the one or moredisplay windows for indicating to the user that the injection of thefluid product is finished by showing through said at least one displaywindow said at least one deformable foot of said pellet support; theautoinjector further comprising: a reservoir displacement deviceconfigured to displace the needle towards an injection position in whichthe needle is inserted in the body of the user and configured to retractsaid needle out of the body of the user after injection of the fluidproduct, said actuating sleeve, in the actuation position, actuatingsaid reservoir displacement device to move the needle towards theinjection position, said reservoir displacement device unblocking saidinjection lock and actuating the injection means when the needle is inthe injection position, in which said injection means actuate saidreservoir displacement device after injection of the fluid product toretract said needle; and a retarding device adapted to retard during apredetermined time the actuation of said reservoir displacement deviceby said injection means after injection of the fluid product, to delayretraction of said needle of said predetermined time after the end ofthe injection.
 19. The autoinjector according to claim 18, in which oneof said one or more display windows for indicating the flow of saidpredetermined time to the user.